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A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

Primary Purpose

HPV InfectioN, HPV-Related Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)
placebo
Sponsored by
National Vaccine and Serum Institute, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HPV InfectioN focused on measuring HPV Infection HPV vaccine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

- non-gynecological related

  1. *Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
  2. *Axillary body temperature <37.3℃ on the day of enrollment;
  3. The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
  4. Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;
  5. No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;
  6. The subject has a negative urine pregnancy test on the day before vaccination.

    - Gynecology related

  7. *Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.
  8. *Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina), no vaginal drugs or preparations are used.

Exclusion Criteria:

First dose exclusion criteria:

(Visits may be rescheduled if the criteria described in the "*" option are met at screening)

- Non-gynecological related

  1. * Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;
  2. *3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
  3. *Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
  4. *3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
  5. History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.);
  6. Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease;
  7. 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited;
  8. Previous splenectomy or impaired spleen function;
  9. Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;
  10. Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;
  11. Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;
  12. Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;
  13. The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.).

    - Gynecology related

  14. *Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine;
  15. *The subject is in the menstrual period;
  16. *Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination;
  17. Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.);
  18. Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.);
  19. Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia.

Exclusion criteria for 2nd and 3rd dose vaccination:

If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine.

  • Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12;
  • Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.

Sites / Locations

  • Hechi Yizhou District Center for Disease Control and Prevention
  • Hezhou Center for Disease Control and Prevention
  • Lianyuan Center for Disease Control and PreventionRecruiting
  • Qiyang Center for Disease Control and PreventionRecruiting
  • Yongji Center for Disease Control and Prevention
  • Yuanqu Center for Disease Control and Prevention
  • Mianyang Youxian District Center for Disease Control and Prevention
  • Neijiang Shizhong District Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experiment group

placebo

Arm Description

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Outcomes

Primary Outcome Measures

Person-years incidence of CIN2+ associated with HPV6/11/16/18.
Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68

Secondary Outcome Measures

Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types.
Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV31/33/45/52/58/59/68
Person-years incidence of CIN2+, CIN1+, PI12 and PI6 associated with HPV6/11/16/18/31/33/45/52/58/59/68 types.
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
AE incidence and severity distribution
AE incidence and severity distribution
SAE incidence
Number of pregnant
Obtain pregnancy outcomes in pregnant subjects( pregnancy event report form)
Previous pregnancy, current pregnancy mode, neonatal information
To evaluate the positive conversion rate of neutralizing antibodies in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
To evaluate the GMT in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)

Full Information

First Posted
January 27, 2022
Last Updated
June 5, 2022
Sponsor
National Vaccine and Serum Institute, China
Collaborators
Chengdu Institute of Biological Products Co.,Ltd., Simoon Record Pharma Information Consulting Co., Ltd., Beijing Kantorico Statistical Technology Co., Ltd., Guangxi Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Shanxi Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05262010
Brief Title
A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
Official Title
A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2022 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Vaccine and Serum Institute, China
Collaborators
Chengdu Institute of Biological Products Co.,Ltd., Simoon Record Pharma Information Consulting Co., Ltd., Beijing Kantorico Statistical Technology Co., Ltd., Guangxi Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Shanxi Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV InfectioN, HPV-Related Carcinoma
Keywords
HPV Infection HPV vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experiment group
Arm Type
Experimental
Arm Description
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo
Intervention Type
Biological
Intervention Name(s)
11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)
Intervention Description
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo
Primary Outcome Measure Information:
Title
Person-years incidence of CIN2+ associated with HPV6/11/16/18.
Time Frame
1 month after 3 doses of vaccine
Title
Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68
Time Frame
1 month after 3 doses of vaccine
Secondary Outcome Measure Information:
Title
Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types.
Time Frame
1 month after 3 doses of vaccine
Title
Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58
Time Frame
1 month after 3 doses of vaccine
Title
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6
Time Frame
1 month after 3 doses of vaccine
Title
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Time Frame
1 month after 3 doses of vaccine
Title
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18
Time Frame
After at least 1 dose of vaccine
Title
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV31/33/45/52/58/59/68
Time Frame
After at least 1 dose of vaccine
Title
Person-years incidence of CIN2+, CIN1+, PI12 and PI6 associated with HPV6/11/16/18/31/33/45/52/58/59/68 types.
Time Frame
After at least 1 dose of vaccine
Title
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Time Frame
After at least 1 dose of vaccine
Title
AE incidence and severity distribution
Time Frame
The first dose of vaccination to within 1 month after the full vaccination
Title
AE incidence and severity distribution
Time Frame
0-30 days after each dose vaccination (including 30 minutes, 0-7 days, 8-30 days)
Title
SAE incidence
Time Frame
During the study,an average of 6 year
Title
Number of pregnant
Time Frame
The first dose of vaccination to within 6 months after the full vaccination
Title
Obtain pregnancy outcomes in pregnant subjects( pregnancy event report form)
Description
Previous pregnancy, current pregnancy mode, neonatal information
Time Frame
The first dose of vaccination to within 6 months after the full vaccination
Title
To evaluate the positive conversion rate of neutralizing antibodies in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
Time Frame
7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination
Title
To evaluate the GMT in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
Time Frame
7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination
Other Pre-specified Outcome Measures:
Title
Person-years incidence of PI12 and PI6 associated with HPV59/68
Time Frame
1 month after 3 doses of vaccine
Title
Person-years incidence of PI12 and PI6 associated with HPV59/68
Time Frame
1 month after 1 doses of vaccine

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - non-gynecological related *Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification; *Axillary body temperature <37.3℃ on the day of enrollment; The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent; Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits; No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of; The subject has a negative urine pregnancy test on the day before vaccination. - Gynecology related *Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan. *Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina), no vaginal drugs or preparations are used. Exclusion Criteria: First dose exclusion criteria: (Visits may be rescheduled if the criteria described in the "*" option are met at screening) - Non-gynecological related * Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination; *3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment; *Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days; *3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.); History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.); Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease; 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited; Previous splenectomy or impaired spleen function; Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors; Have a history of epilepsy, convulsions, mental illness or a family history of mental illness; Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection; Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period; The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.). - Gynecology related *Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine; *The subject is in the menstrual period; *Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination; Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.); Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.); Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia. Exclusion criteria for 2nd and 3rd dose vaccination: If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine. Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12; Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaojun Mo
Phone
(+86)15177771508
Email
mozhj@126.com
Facility Information:
Facility Name
Hechi Yizhou District Center for Disease Control and Prevention
City
Hechi
State/Province
Guangxi
ZIP/Postal Code
546300
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ming han
Phone
(+86)18934923075
Facility Name
Hezhou Center for Disease Control and Prevention
City
Hezhou
State/Province
Guangxi
ZIP/Postal Code
542899
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian biao Li
Phone
(+86)18978463935
Facility Name
Lianyuan Center for Disease Control and Prevention
City
Lianyuan
State/Province
Hunan
ZIP/Postal Code
417100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Deng
Phone
(+86)13789255955
Facility Name
Qiyang Center for Disease Control and Prevention
City
Qiyang
State/Province
Hunan
ZIP/Postal Code
426100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Tan
Phone
(+86)18974676669
Facility Name
Yongji Center for Disease Control and Prevention
City
Yongji
State/Province
Shanxi
ZIP/Postal Code
044500
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Yan
Phone
(+86)15835919188
Facility Name
Yuanqu Center for Disease Control and Prevention
City
Yuncheng
State/Province
Shanxi
ZIP/Postal Code
043700
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohong Cui
Phone
(+86)13903488150
Facility Name
Mianyang Youxian District Center for Disease Control and Prevention
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gang Xie
Phone
(+86)13778031535
Facility Name
Neijiang Shizhong District Center for Disease Control and Prevention
City
Neijiang
State/Province
Sichuan
ZIP/Postal Code
641000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling zhong
Phone
(+86)18981435233

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

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